Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT01007474 |
| Other study ID # |
MDT-OHCS |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2004 |
| Est. completion date |
January 2030 |
Study information
| Verified date |
February 2021 |
| Source |
Medtronic Italia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The One Hospital ClinicalService Project is an integrated system composed by a network of
International Hospital Departments, a clinical data repository and a shared environment for
the collection, management, analysis and reporting of clinical and diagnostics data from
patients treated by Medtronic therapies or patients wearing Medtronic implantable devices
used within their intended use. The One Hospital ClinicalService is composed by a suite of
systematic, data-guided activities designed to bring about immediate improvements in health
delivery in particular settings. Data are prospectively collected. An independent committee
of physicians prospectively identifies key clinical questions on a yearly basis for
development of quality improvement activities, analyses and publications. A charter, approved
by Hospital Istitutional Review Boards or other Hospital entities, assigns the ownership of
data to the centers and governs the conduct of the project and the relationship of the
scientific committee and Medtronic. Hospital is the data controller, while Medtronic is the
data processor on behalf of the Hospital. Data collected for quality improvement purposes may
be mined to perform clinical research.
Description:
One Hospital ClinicalService is a project aiming to provide information and analysis of
clinical and device data, back to the treating healthcare providers regarding their own
patients, in order to help those healthcare providers improve outcomes and understanding of
their patients' care or patients' management.
The mission of the One Hospital ClinicalService Project is to improve outcomes and
comprehension of diagnostic and therapeutic strategies applied to patients wearing Medtronic
implantable devices or treated by Medtronic therapies. One Hospital ClinicalService provides
services to evaluate and improve the quality of clinical care in the International clinical
practice.
One Hospital ClinicalService collects acute and chronic patient and device data in a large
population during routine usage of the device, without specific study interventions, and
always within the approved intended use of the device.
One Hospital ClinicalService uses a core database which can be expanded with specific data
sets for particular patient populations, diseases, therapies, devices or features.
One Hospital ClinicalService, with its prospective data collection and its data management
infrastructure, forms a data-bank where physicians collect patient data and from which they
receive reports about clinical and device diagnostics data. Usage and understanding of
diagnostics data may help physicians to optimize tailor device programming and patient
therapies. This data-bank, queried by retrospective statistical analyses, may help physicians
in quality improvement activities, education, research and scientific activities.
Some examples of scientific focus available through the One Hospital ClinicalService Project
include:
- Describing the use of implantable devices, such as cardioverter defibrillator (ICD),
pacemakers, implantable loop recorders or others in the Italian clinical practice
- Identifying predictors or clinical variables correlated with clinical outcomes or
therapy response
- Evaluating and testing methods to optimize device programming and patient therapy via
device diagnostics or patient reports
